MedPath

Walking Gait Biomechanics Following Knee Joint Effusion

Not Applicable
Recruiting
Conditions
Knee Osteoarthritis
Knee Injuries
Interventions
Other: Knee Joint Effusion
Registration Number
NCT03805464
Lead Sponsor
Duke University
Brief Summary

The purpose of this study is to determine the sensitivity of a wearable sensor to detect changes in knee joint loading using an experimental knee joint effusion as a model for a common clinical physiological alteration in joint status. The rationale for this project is that it will establish the efficacy of an inexpensive, clinically, and publicly available device that can detect changes in biomechanical loading due to acute physiologic change in joint status. The study will utilize a cross-sectional cohort study design and will seek to enroll 25 male and female healthy adult participants (18-35 yo). Participants will report to the laboratory for three total sessions (Session 1: informed consent and task familiarization; Session 2: testing; Session 3: knee joint status assessment). The primary outcomes of interest include lower extremity thigh and shank acceleration and velocity data (wearable sensor data), lower extermity 3D kinematics and kinetics (motion capture data), and lower extremity muscle function (EMG data) during walking gait, as well as functional balance and patient-reported subjective outcomes. Data will be analyzed by calculating change scores from the pre- to post-experimental effusion outcome measure testing. Paired-samples t-tests and Cohen's d effect sizes will be used to assess changed in wearable sensor data from pre- to post-experimental effusion. Correlation statistics will be used to determine if there are association between the motion capture and wearable sensor data. The potential risks associated with an experimental joint effusion will be addressed by maintaining appropriate sterile conditions and having the participant check-in with the PI (licensed healthcare provider) at 48 hours following testing session.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
25
Inclusion Criteria
  • Male and female
  • Chronological age 18-35 at the time of study participation
  • Physically active (at least 30 minutes of physical activity, 3x/week)
  • Tegner Activity Scale score at least 5/10
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Exclusion Criteria
  • History of lower extremity or lumbar spine surgery.
  • History of lower extremity or lumbar spine injury in the prior 6 months.
  • History of major ligamentous damage.
  • Current knee pain.
  • Known neurological condition, autoimmune condition, cardiovascular disease.
  • History of epilepsy, seizures, concussion within the prior 6 months.
  • Currently taking pain altering medication.
  • Fear of needles
  • Unable to read and understand English language
  • Pregnancy
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Knee Joint EffusionKnee Joint EffusionParticipants will receive a one-time injection of 60mL of sterile saline into the suprapatellar space of the dominant lower extremity. This injection will be conducted under ultrasound guidance by a board-certified orthopedic surgeon.
Primary Outcome Measures
NameTimeMethod
Change in Peak Internal Knee Extension MomentImmediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Kinetic Loading Variable

Change in Shank Angular VelocityImmediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Gyroscope Variable

Change in Thigh Angular VelocityImmediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Gyroscope Variable

Change in Peak Vertical Ground Reaction ForceImmediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Kinetic Loading Variable

Change in Peak Knee PowerImmediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Kinetic Loading Variable

Change in Thigh AccelerationImmediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Accelerometer Variable

Change in Shank AccelerationImmediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Accelerometer Variable

Secondary Outcome Measures
NameTimeMethod
Change in Hamstring EMGImmediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Muscle Activity Variable

Change in Visual Analog Scale PainImmediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Pain Variable

Change in Quadriceps EMGImmediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Muscle Activity Variable

Change in International Knee Documentation CommitteeImmediately Pre- (10 minutes) and Post- (10 minutes) Effusion

Self-Reported Disability Variable

Trial Locations

Locations (1)

Michael W. Krzyzewski Human Performance Laboratory

🇺🇸

Durham, North Carolina, United States

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